An Observational Study in Type 2 Diabetic Patients on Oral Antidiabetic Drugs and Basal Insulin in Near East Countries (BO2NE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00842192
First received: February 11, 2009
Last updated: June 28, 2012
Last verified: April 2012

February 11, 2009
June 28, 2012
April 2009
August 2010   (final data collection date for primary outcome measure)
  • Change in number of hypoglycaemic events from baseline [ Time Frame: at 12 and 24 weeks ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: at 12 and 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00842192 on ClinicalTrials.gov Archive Site
  • Percentage of subjects to reach HbA1c between 6.5 and 7.0% [ Time Frame: at 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Glucose variability as measured by FPG [ Time Frame: at 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Postprandial glycaemic control as measured by PPG [ Time Frame: at 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Insulin dose and number of injections [ Time Frame: at 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: at 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Number of adverse drug reactions (ADR) [ Time Frame: at 12 and 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
An Observational Study in Type 2 Diabetic Patients on Oral Antidiabetic Drugs and Basal Insulin in Near East Countries
A Prospective, Multicentre, Multinational, Open Label, Non-controlled, Observational, 24-week Study in Patients Using Oral Anti-Diabetic (OAD) Drugs + Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus in Near East Region Countries

This study is conducted in Asia. The aim of this observational study is to investigate the safety and efficacy of insulin detemir as add-on therapy in type 2 diabetic patients who are using oral antidiabetic drugs

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Any subject with type 2 diabetes who is newly diagnosed or treated with OADs only is eligible for the study. The selection of the subjects as well as the treatment insulin will be at the discretion of the individual physician based on clinical judgement.

  • Diabetes
  • Diabetes Mellitus, Type 2
Drug: insulin detemir
Insulin detemir for s.c. injection, once daily, in addition to current OAD treatment. Dose to be determined by physician.
Other Names:
  • NN304
  • Levemir®
A
Intervention: Drug: insulin detemir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2154
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • After the physician decision has been made to use insulin detemir therapy, any subject with Type 2 diabetes who is treated with any one or more of the oral antidiabetic drug (metformin, SU, repaglinide, TZDs) is eligible for the study. The selection of the subjects will be at the discretion of the individual physician. Particular attention should be paid to the drug interactions that are listed within the product label

Exclusion Criteria:

  • Subjects currently being treated with insulin detemir or any other insulin regimen including regular(bolus) insulin
  • Subjects with a hypersensitivity to insulin detemir or to any of the excipients
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months. Women of childbearing potential who are not using adequate contraceptive methods
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Israel,   Jordan,   Lebanon,   Pakistan
 
NCT00842192
NN304-3735
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Elif Coskuncay Yener, MD Novo Nordisk Regional Office Near East
Novo Nordisk A/S
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP